ASSAY KIT, THROMBO-SCREEN

Test, Fibrinogen

PACIFIC HEMOSTASIS

The following data is part of a premarket notification filed by Pacific Hemostasis with the FDA for Assay Kit, Thrombo-screen.

Pre-market Notification Details

Device IDK781880
510k NumberK781880
Device Name:ASSAY KIT, THROMBO-SCREEN
ClassificationTest, Fibrinogen
Applicant PACIFIC HEMOSTASIS 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeGIS  
CFR Regulation Number864.7340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-11-06
Decision Date1978-12-04

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00845275000856 K781880 000
00845275000849 K781880 000
00845275000627 K781880 000
00845275000597 K781880 000
00845275000580 K781880 000

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